Improving Neurologic Outcomes in People With Diabetes Who Are Undergoing Heart Surgery
Improving Neurologic Outcomes in Diabetics Undergoing Cardiac Surgery
研究概览
详细说明
People with diabetes who undergo heart surgery have a greater risk of experiencing a stroke and developing cognitive functioning problems than people without diabetes who undergo heart surgery. There may be a connection between disturbances in glucose metabolism, endothelial dysfunction, and poor neurological outcomes after heart surgery. People with diabetes who receive more intensive blood glucose management during and after heart surgery may have better neurological outcomes than people who control their blood glucose levels in a standard way. The purpose of this study is to evaluate the effectiveness of using a traditional method of controlling blood glucose levels versus a tailored, more intensive method of glucose control on neurological outcomes in people with diabetes who are undergoing heart surgery. Researchers will also examine genetic factors that may be associated with insulin resistance and inflammation.
This study will enroll people undergoing heart surgery. On the day before surgery, participants will undergo a blood collection and neuropsychological testing. They will then be randomly assigned to either a traditional method of blood glucose control or an intensive, tailored method of blood glucose control. Participants following the traditional method of blood glucose control may receive insulin several times a day, based on the results of glucose monitoring. Participants following the intensive, tailored method of blood glucose control will undergo hourly measurements of their glucose levels and receive insulin adjustments as needed to maintain a glucose level of 100-140 mg/dL. During surgery, all participants will undergo an ultrasound of their neck to monitor blood vessel activity. Additional blood samples will be collected during surgery, 6 hours after surgery, 24 hours after surgery, and upon hospital discharge or 5 days after surgery.
One week after surgery or just before leaving the hospital, participants will undergo a magnetic resonance imaging (MRI) procedure and neuropsychological testing. Before leaving the hospital, participants will take part in a diabetes education session and nutrition counseling. Three to 6 weeks and 6 months after surgery, participants will undergo repeat neuropsychological testing. Once a month for 6 months, participants who received the intensive, tailored method of blood glucose control will attend study visits at which time study researchers will monitor their diabetes.
研究类型
注册 (实际的)
阶段
- 第三阶段
联系人和位置
学习地点
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North Carolina
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Winston-Salem、North Carolina、美国、27057
- Wake Forest Baptist Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- History of diabetes, elevated fasting blood glucose, elevated hemoglobin A1c, or elevation of these variables during the current hospital admission
- Scheduled to undergo coronary artery bypass graft (CABG) surgery
- Scheduled to undergo aortic valve replacement (AVR), mitral valve replacement (MVR), or both
- Scheduled to undergo valve replacement with CABG
Exclusion Criteria:
- Undergoing emergent (i.e., urgent) procedures
- Alzheimer's disease or similar dementias
- Severe claustrophobia
- Kidney insufficiency, as defined by serum creatine levels greater than 2.0 mg/dL
- Cannot be expected to complete neuropsychological testing
- Recent extensive, life threatening acute myocardial infarction (AMI)
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:Intensive Glucose Management
Participants will receive intensive glucose management.
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Participants in the intensive glucose management group will undergo strict management of their blood glucose levels with a target whole blood glucose level of 100-140 mg/dL preoperatively, intraoperatively, and postoperatively in the intensive care unit (ICU).
Once meals are started, targets for glycemia management will be (a) fasting: 80-140 mg/dL, (b) postprandial: 140-180 mg/dL.
Prior to hospital discharge, participants will receive an in-depth diabetes education session.
After hospital discharge, participants will attend monthly study visits for 6 months so that study researchers can monitor their glycemia management.
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有源比较器:Traditional Glucose Management
Participants will receive a traditional method of glucose management.
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Participants will receive traditional management of blood glucose levels while in the hospital.
They may receive insulin several times a day, based on the results of glucose monitoring.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Proportion of participants with identifiable brain lesions detected by magnetic resonance imaging (MRI)
大体时间:Measured 1 week after surgery
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Measured 1 week after surgery
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Proportion of participants with new neuropsychological deficits (20% decline on two or more neuropsychological tests)
大体时间:Measured 6 months after surgery
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Measured 6 months after surgery
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Number of lesions, as measured by MRI
大体时间:Measured 1 week after surgery
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Measured 1 week after surgery
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Size of lesions, as measured by MRI
大体时间:Measured 1 week after surgery
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Measured 1 week after surgery
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Genetic analysis (i.e., predictive utility of haplotype assignment on primary outcomes)
大体时间:Measured 6 months after surgery
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Measured 6 months after surgery
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Neuropsychological deficits (i.e., predictive utility of neuropsychological performance on presence, number, and volume of lesions)
大体时间:Measured 6 months after surgery
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Measured 6 months after surgery
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合作者和调查者
调查人员
- 首席研究员:Edward H. Kincaid, MD、Wake Forest University Health Sciences
- 研究主任:Jorge Calles-Escandon, MD、Wake Forest University Health Sciences
- 研究主任:Donald W. Bowden, PhD、Wake Forest University Health Sciences
- 研究主任:David A. Stump, PhD、Wake Forest University Health Sciences
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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